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Updated MHRA Guidance on marketing authorisation and on medical devices

Updated MHRA Guidance on marketing authorisation and on medical devices
January 28, 2021 SueCarr

The MHRA has released some new and updated guidance on marketing authorisations and devices.

Guidance on handling of Decentralised and Mutual recognition Procedures which are approved or pending (new)

This guidance describes the MHRA’s approach for products already approved or that were included in ongoing decentralised procedures (DCP) or mutual recognition procedures (MRP) with UK as a Concerned Member State (CMS).

The most recent update clarifies that UK national MA applications can be submitted irrespective of applications for the same product in the EU and highlights options for ongoing procedures that were not completed by 31 December 2020. Read more.

 

Single-use medical devices: implications and consequences of re-use (update)

This updated guidance covers the legal implications, negligence, regulatory requirements and safety issues on single-use medical devices. A new PDF version has been uploaded to reflect changes to regulations following Brexit. Read more.

 

Measurement of in vitro diagnostic medical devices (update)

This publication addresses aspects that are important in the procurement of in vitro diagnostic medical devices (IVDs) and in their safety, quality and performance. A new PDF version has been uploaded to reflect changes to regulations following Brexit. Read more.